EMR200084_512: Risk of lactic acidosis with metformin use in type 2 diabetes mellitus with renal impairment: retrospective cohort study

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prescription event monitoring

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  METFORMIN
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BA02) metformin

  metformin
• Medical condition to be studied:
  Diabetes mellitus

  Renal impairment

Population studied

• Short description of the study population:
  Patients who were diagnosed with Type 2 Diabetes Mellitus (T2DM) with or without therapy. Patients were be included if: 1) had at least one measure of Glomerular Filtration Rate (GFR) between 2007-2012 or their chronic kidney disease (CKD) measured; 2) regardless of T2DM diagnoses date, 3) with or without therapy, 4) regardless of whether they were using insulin concomitant to other OAD drugs, and 5) have at least 1 follow-up during the study period.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  135000

Study design details

• Study design:
  This is a retrospective cohort study in observational data
• Main study objective:
  To estimate the incidence of lactic acidosis associated with metformin use in patients with moderate renal impairment (GFR 30-59ml/min) compared to patients with a GFR >60 ml/min.
• Setting:
  This study will be conducted using the Clinical Practice Research Datalink (CPRD). The CPRD is the English NHS observational data and interventional research service and will be the primary data source for patients in the United Kingdom.
• Outcomes:
  incidence of lactic acidosis
• Data analysis plan:
  Data analysis will consist of incidence rates in 100,000 person-years of lactic acidosis in patients with T2DM using metformin and having different CKD staging. A secondary analysis of the incidence of LA in patients using Metformin versus those using other antidiabetic drugs by stages of CKD will be performed. Lactic acidosis includes both cases of fatal and cases of non-fatal lactic acidosis. Upper and lower limits of 95% confidence intervals will be given.